NanoViricides's
Broad-Spectrum Antiviral Drug Candidate for the Treatment of
COVID-19 Infections was Well Tolerated in GLP and non-GLP Animal
Safety Studies
SHELTON, CT / InvestorsHub
NewsWire / February 8, 2021
/ NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a global leader in the
development of highly effective broad-spectrum antiviral therapies
based on a novel nanomedicines platform has announced today that
its broad-spectrum anti-coronavirus drug candidate for the
treatment of COVID-19 infections was well tolerated in safety
pharmacology studies required for progressing to human clinical
trials.
The Company reports that its drug
candidate NV-CoV-2 was found to be safe in the GLP safety
pharmacology studies performed by an external contract research
organization (CRO) in both rat and non-human primate (NHP) models.
Additionally, multiple injections of NV-CoV-2 were also well
tolerated in an extensive non-GLP study in rats that was performed
by AR Biosystems, Inc., FL.
Based on the safety of NV-CoV-2 in
these studies, the Company believes that projected dosages would be
safe in human clinical trials. With these findings, the Company
believes that it will be possible to administer repeated dosages of
NV-CoV-2 in a human clinical trial, if needed, to achieve control
over the coronavirus infection from SARS-CoV-2 or its
variants.
In a GLP neuro-pulmonary safety
pharmacology study in rats, the following conclusion was drawn: The
intravenous administration of NV-CoV-2 at doses of 25, 50 and 100
mg/kg did not affect respiratory function in rats.
In a GLP cardiovascular function study
in the NHP cynomolgus monkeys, the following conclusion was drawn:
Intravenous infusion of NV-CoV-2 at 25, 37.5, and 50 mg/kg did not
have any toxicologic effects on cardiac rhythm or ECG morphology in
cynomolgus monkeys in this study. No significant effects on blood
pressure and heart rate were observed after the intravenous
infusion of NV-CoV-2.
These results were consistent with a
more extensive, multiple injection non-GLP safety and tolerability
study in Sprague-Dawley male and female rats. In this non-GLP
study, NV-CoV-2 was injected intravenously (via tail vein) on each
of days 0, 1, 2, 3, 4, and 5. Two different doses were used:
320mg/kg BW per injection, and 160 mg/kg BW per injection. Clinical
observations, body weight, urine, blood chemistry, post-mortem
findings, and organ histology were studied. In all parameters,
NV-CoV-2 was well tolerated at both dosages throughout the
study.
The Company has received draft reports
from all of these studies. We anticipate receiving final audited
reports on the GLP studies shortly.
The Company is preparing to submit a
pre-IND application to the US FDA with safety tolerability and
effectiveness data to obtain guidance regarding human clinical
trials. Additionally, we are actively seeking opportunities to
engage appropriate sites for human clinical trials. Further, we are
engaged in the preparation of clinical trial protocols and other
activities that would be necessary for submitting an IND
application to the US FDA.
The need for the broad-spectrum,
pan-coronavirus nanoviricide drug treatment cannot be overstated
for combating the COVID-19 pandemic given the current circumstances
and the present status of the pandemic. New virus variants continue
to develop in the field. The variants that have advantages in terms
of transmissibility, infectivity, and escape from drugs and
vaccines will continue to evolve and spread, replacing prior
variants. This is already well documented.
Several vaccines have been found to be
substantially less effective in protecting against infection by the
South African variant, N501Y-V.2 (also called lineage B.1.351) than
the earlier variants. A mutation present in B.1.351 as well as
Brazilian variant P.1 that is thought to be possibly linked to
evasion from antibody drugs and vaccines, E484K, has also been
reported in UK in a further differentiated mutant of the variant of
concern lineage B.1.1.7. The available monoclonal antibody drugs
and convalescent plasma antibodies have been reported to be less
effective against several variants.
By the very nature of how they work,
vaccines and antibodies tend to be highly specific to the target
virus variant, and do not afford strong protection against
differentiated variants that are evolutionary distant from the
target variant. This scientific fact is now well demonstrated for
the COVID-19 pandemic.
It is therefore clear that an
effective broad-spectrum anti-coronavirus drug will be needed
before the world can return to normal activity.
The Company previously had advanced
NV-CoV-1 and had continued to work further with additional drug
candidates. One of these drug candidates, namely, NV-CoV-2 was
found to have several advantages over NV-CoV-1 in terms of
manufacturability and dose formulation. Therefore the Company has
advanced NV-CoV-2 into GLP safety/pharmacology studies.
NanoViricides is developing a
broad-spectrum antiviral drug where the potential for escape of
virus variants is minimized by the very design of the drug for the
treatment of COVID-19 infected sick persons. In contrast, vaccines
are not treatments for sick persons, and must be administered to
healthy individuals, and further require several weeks for the
recipient's immune system to become capable of protecting against
the target virus strain which still may not protect against new
virus variants circulating by that time.
NanoViricides has a strong advantage
in that the Company has its own cGMP-capable manufacturing facility
in Shelton, CT. This facility is capable of producing approximately
4kg of the COVID-19 drug per batch. We anticipate that this would
be sufficient for human clinical trials, and possibly for initial
introduction under Compassionate Use, Emergency Use Authorization
or similar regulatory approval.
"We are pleased with the results of
the safety pharmacology studies, and now we are confident that our
COVID-19 drug candidate can advance into human clinical trials,"
said Anil R. Diwan, PhD, President and co-Founder of NanoViricides,
Inc., and co-Inventor of its platform technologies and drug
candidates.
About NanoViricides
NanoViricides, Inc. (the
"Company")(www.nanoviricides.com) is a development stage
company that is creating special purpose nanomaterials for
antiviral therapy. The Company's novel nanoviricide® class of drug
candidates are designed to specifically attack enveloped virus
particles and to dismantle them. Our lead drug candidate is
NV-HHV-101 with its first indication as dermal topical cream for
the treatment of shingles rash. In addition, we are developing a
clinical candidate for the treatment of COVID-19 disease caused by
SARS-CoV-2 coronavirus. The Company cannot project an exact date
for filing an IND for this drug because of its dependence on a
number of external collaborators and consultants.
The Company is now working on tasks
for completing an IND application. The Company is currently
pursuing two separate drug candidates for the treatment of COVID-19
patients. NV-CoV-2 is our nanoviricide drug candidate that does not
encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that
is made up of NV-CoV-2 with remdesivir encapsulated in it. The
Company believes that since remdesivir is already US FDA approved,
our drug candidate encapsulating remdesivir is likely to be an
approvable drug, if safety is comparable. Remdesivir is developed
by Gilead. The Company has developed both of own drug candidates
NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into
an IND application to the US FDA for NV-HHV-101 drug candidate for
the treatment of shingles once its COVID-19 project moves into
clinical trials, based on resources availability. The NV-HHV-101
program was slowed down because of the effects of recent COVID-19
restrictions, and re-prioritization for COVID-19 drug development
work.
The Company is also developing drugs
against a number of viral diseases including oral and genital
Herpes, viral diseases of the eye including EKC and herpes
keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV,
Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
NanoViricides' platform technology and programs are based on the
TheraCour® nanomedicine technology of TheraCour, which TheraCour
licenses from AllExcel. NanoViricides holds a worldwide exclusive
perpetual license to this technology for several drugs with
specific targeting mechanisms in perpetuity for the treatment of
the following human viral diseases: Human Immunodeficiency Virus
(HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster
Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses,
Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg
viruses. The Company has executed a Memorandum of Understanding
with TheraCour that provides a limited license for research and
development for drugs against human coronaviruses. The Company
intends to obtain a full license and has begun the process for the
same. The Company's technology is based on broad, exclusive,
sub-licensable, field licenses to drugs developed in these areas
from TheraCour Pharma, Inc. The Company's business model is based
on licensing technology from TheraCour Pharma Inc. for specific
application verticals of specific viruses, as established at its
foundation in 2005.
As is customary, the Company must
state the risk factor that the path to typical drug development of
any pharmaceutical product is extremely lengthy and requires
substantial capital. As with any drug development efforts by any
company, there can be no assurance at this time that any of the
Company's pharmaceutical candidates would show sufficient
effectiveness and safety for human clinical development. Further,
there can be no assurance at this time that successful results
against coronavirus in our lab will lead to successful clinical
trials or a successful pharmaceutical product.
This press release contains
forward-looking statements that reflect the Company's current
expectation regarding future events. Actual events could differ
materially and substantially from those projected herein and depend
on a number of factors. Certain statements in this release, and
other written or oral statements made by NanoViricides, Inc. are
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. You should not place undue reliance on
forward-looking statements since they involve known and unknown
risks, uncertainties and other factors which are, in some cases,
beyond the Company's control and which could, and likely will,
materially affect actual results, levels of activity, performance
or achievements. The Company assumes no obligation to publicly
update or revise these forward-looking statements for any reason,
or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, even if
new information becomes available in the future. Important factors
that could cause actual results to differ materially from the
company's expectations include, but are not limited to, those
factors that are disclosed under the heading "Risk Factors" and
elsewhere in documents filed by the company from time to time with
the United States Securities and Exchange Commission and other
regulatory authorities. Although it is not possible to predict or
identify all such factors, they may include the following:
demonstration and proof of principle in preclinical trials that a
nanoviricide is safe and effective; successful development of our
product candidates; our ability to seek and obtain regulatory
approvals, including with respect to the indications we are
seeking; the successful commercialization of our product
candidates; and market acceptance of our products.
FDA refers to US Food and Drug
Administration. IND application refers to "Investigational New
Drug" application. cGMP refers to current Good Manufacturing
Practices. CMC refers to "Chemistry, Manufacture, and Controls".
CHMP refers to the Committee for Medicinal Products for Human Use,
which is the European Medicines Agency's (EMA) committee
responsible for human medicines.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations
Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides,
Inc.